U.S. patent application number 13/014269 was filed with the patent office on 2011-08-04 for therapeutic balloon with systemic drug loss protection and controlled particle size release.
This patent application is currently assigned to BOSTON SCIENTIFIC SCIMED, INC.. Invention is credited to James Anderson, Tim Ostroot, Derek Sutermeister.
Application Number | 20110190863 13/014269 |
Document ID | / |
Family ID | 43806732 |
Filed Date | 2011-08-04 |
United States Patent
Application |
20110190863 |
Kind Code |
A1 |
Ostroot; Tim ; et
al. |
August 4, 2011 |
Therapeutic Balloon with Systemic Drug Loss Protection and
Controlled Particle Size Release
Abstract
Systemic drug loss protection devices are disclosed. The drug
loss protection device includes a balloon and a drug particulate
filter. The drug particulate filter has a plurality of openings and
is configured to selectively permit transmission of drug
particulates through the filter. Consequently, the size of the
openings in the filter regulates transmission of the drug
particulates. The drug particulate filter can also be used as an
embolic filter.
Inventors: |
Ostroot; Tim; (Cokato,
MN) ; Sutermeister; Derek; (Eden Prairie, MN)
; Anderson; James; (Fridley, MN) |
Assignee: |
BOSTON SCIENTIFIC SCIMED,
INC.
Maple Grove
MN
|
Family ID: |
43806732 |
Appl. No.: |
13/014269 |
Filed: |
January 26, 2011 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
61301018 |
Feb 3, 2010 |
|
|
|
Current U.S.
Class: |
623/1.11 ;
604/103.02 |
Current CPC
Class: |
A61F 2230/0069 20130101;
A61F 2230/0006 20130101; A61F 2310/0097 20130101; A61F 2/958
20130101; A61F 2002/018 20130101; A61F 2230/0067 20130101; A61F
2/013 20130101 |
Class at
Publication: |
623/1.11 ;
604/103.02 |
International
Class: |
A61M 25/10 20060101
A61M025/10; A61F 2/84 20060101 A61F002/84 |
Claims
1. An intravascular drug loss protection device comprising: a
drug-coated balloon comprising a drug coating; and a drug
particulate filter distal to the drug-coated balloon, the drug
particulate filter comprising a mesh, the mesh defining a plurality
of openings configured to selectively prevent the passage of drug
particulates therethrough.
2. The drug loss protection device of claim 1, wherein the
drug-coated balloon and drug particulate filter each comprise a
delivery configuration, an expanded configuration, a post-expansion
configuration, and an unexpanded configuration; the drug-coated
balloon having a profile in each of the delivery configuration,
expanded configuration, post-expansion configuration, and
unexpanded configuration; the particulate filter having a profile
in each of the delivery configuration, expanded configuration,
post-expansion configuration, and unexpanded configuration; the
profile of the drug-coated balloon in the expanded configuration
being larger than in each of the delivery configuration,
post-expansion configuration, and the unexpanded configuration; the
profile of the particulate in the expanded configuration being the
same as in the post-expansion configuration.
3. The drug loss protection device of claim 1, wherein the drug
particulate filter has a proximal end and a distal end, the drug
particulate filter tapering from the proximal end to the distal
end.
4. The drug loss protection device of claim 1, wherein the
plurality of openings comprises openings of various sizes.
5. The drug loss protection device of claim 1, wherein the
plurality of openings comprises openings that are all the same
size.
6. The drug loss protection device of claim 1, wherein the openings
are between 10 and 500 microns in size.
7. The drug loss protection device of claim 1 further comprising a
stent encircling at least a portion of the drug-coated balloon.
8. The drug loss protection device of claim 7, wherein the stent
comprises a drug eluting stent.
9. The drug loss protection device of claim 1 wherein the filter
has a shape consisting of: semi-spherical, conical, frusto-conical,
cylindrical, semi-cylindrical, and combinations thereof.
10. An intravascular drug loss protection device comprising: a
drug-coated balloon comprising a drug coating; a stent encircling
at least a portion of the drug-coated balloon and engaged thereto;
and a drug particulate filter longitudinally adjacent to the
drug-coated balloon and stent, the drug particulate filter defining
a plurality of openings configured to selectively capture drug
particulates.
11. The drug loss protection device of claim 10, wherein the filter
is attached to a portion of the drug-coated balloon.
12. The drug loss protection device of claim 10, wherein the filter
has a proximal portion, a distal portion, and a tapered profile
tapering from the proximal portion to the distal portion.
13. The drug loss protection device of claim 12, wherein the filter
is frusto-conical.
14. An intravascular drug loss protection device comprising: a drug
coated balloon comprising a drug coating; and a drug particulate
filter encircling at least a portion of the drug coated balloon;
the drug particulate filter comprising a mesh, the mesh defining a
plurality of openings sized to selectively prevent the passage of
drug particulates therethrough.
15. The drug loss protection device of claim 14, wherein the
openings are between 10 and 500 microns in size.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This Application is a non-provisional of application No.
61/301,018, filed Feb. 3, 2010, which is herein incorporated by
reference.
STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH
[0002] Not Applicable.
BACKGROUND
[0003] The use of drug coated intraluminal medical devices is
generally known. Previously known drug coated devices release drug
particulates into a lumen, for example a blood vessel. In
particular, known drug eluting balloons release drug particulates
in an uncontrolled fashion. Particulates of various sizes can flow
into the blood stream without restraint. In some cases, the release
of drugs and drug particulates into a bloodstream can lead to an
undesirable and potentially severe reaction in the patient due to
increased toxicity and systemic loss of the drug or excipient.
[0004] Thus, there remains a need for a medical device that
prevents unregulated release of particulates into a body lumen.
[0005] The art referred to and/or described above is not intended
to constitute an admission that any patent, publication or other
information referred to herein is "prior art" with respect to this
disclosure. In addition, this section should not be construed to
mean that a search has been made or that no other pertinent
information as defined in 37 C.F.R. .sctn.1.56(a) exists.
[0006] All US patents and applications and all other published
documents mentioned anywhere in this application are incorporated
herein by reference in their entirety.
[0007] Without limiting the scope of this disclosure a brief
summary of some of the claimed embodiments is set forth below.
Additional details of the summarized embodiments and/or additional
embodiments of the may be found in the Detailed Description,
below.
BRIEF SUMMARY
[0008] In some embodiments, an intravascular drug loss protection
device comprises an inflatable balloon and a drug particulate
filter adjacent to the inflatable balloon. In some embodiments, the
drug particulate filter comprises a mesh. In some embodiments, the
mesh defines a plurality of openings configured to selectively
capture drug particulates.
BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S)
[0009] FIG. 1 shows a side view of an embodiment of the drug loss
protection device with drug delivery system.
[0010] FIG. 2A shows a side view of the embodiment of the drug loss
protection device of FIG. 1 in a delivery configuration.
[0011] FIG. 2B shows a side view of the embodiment of the drug loss
protection device of FIG. 1 in an expanded configuration.
[0012] FIG. 2C shows a side view of the embodiment of the drug loss
protection device of FIG. 1 in a post-expansion configuration.
[0013] FIG. 2D shows a side view of the embodiment of the drug loss
protection device of FIG. 1 in an unexpanded configuration.
[0014] FIG. 3 shows a detailed view of the embodiment of the drug
loss protection device of FIG. 1.
[0015] FIG. 3B shows a detailed view of an embodiment of the drug
loss protection device.
[0016] FIG. 4 shows a detailed view of the embodiment of the drug
loss protection device of FIG. 1.
[0017] FIG. 5 shows a side view of an embodiment of the drug loss
protection device.
[0018] FIG. 6 shows a side view of an embodiment of the drug loss
protection device.
[0019] FIG. 7 shows a side view of an embodiment of the drug loss
protection device.
DETAILED DESCRIPTION
[0020] While this invention may be embodied in many different
forms, there are described in detail herein specific embodiments.
This description is an exemplification of the principles of the
invention and is not intended to limit the invention to the
particular embodiments illustrated.
[0021] For the purposes of this disclosure, like reference numerals
in the figures shall refer to like features unless otherwise
indicated.
[0022] In at least one embodiment, a balloon catheter comprises a
drug loss protection device having a balloon and a particulate
filter. In some embodiments, the balloon has a drug disposed
thereon. In some embodiments, the drug is applied to an inside of a
body lumen, for example a blood vessel or artery. In some
embodiments, drug particulates no larger than a predetermined size
are permitted to exit the device. In this way, particulates larger
than the predetermined size are prevented from flowing downstream
of the drug loss protection device.
[0023] In some embodiments, for example as shown in FIG. 1, a
balloon catheter 20 comprises a drug loss protection device 10. The
drug loss protection device 10 has a proximal portion 12 and a
distal portion 14. The drug loss protection device 10 has a
particulate filter 22, which, in some embodiments is disposed
adjacent to a balloon 30 along a distal portion 14 of the drug loss
protection device 10. In some embodiments, the particulate filter
22 has a plurality of openings 28 which permit particulates smaller
than a predetermined size to pass through the particulate filter
22. Particulates larger than the predetermined size are prevented
from passing through the particulate filter 22.
[0024] In some embodiments, the particulate filter 22 comprises a
mesh 24 having openings 28. The mesh 24 can comprise openings 28 of
only of one size, or of various sizes. The size of the openings 28
is selected according to the size of particulates which are desired
to pass through the openings. Stated differently, the size of the
openings 28 is selected according to the size of particulates which
are desirably filtered out. In some embodiments, the openings 28
are between 10 and 500 microns.
[0025] As shown in FIG. 1, the drug loss protection device 10 is in
an expanded configuration. Additional configurations are shown in
FIGS. 2A-2D. For example, the drug loss protection device 10 of
FIG. 1 is shown in FIG. 2A in a delivery configuration 2. In FIG.
2B, the drug loss protection device 10 is shown in an expanded
configuration 4. FIG. 2C shows the drug loss protection device 10
in a post-expansion configuration 6, and FIG. 2D shows the
embodiment of FIG. 1 in an unexpanded configuration 8.
[0026] Returning to FIG. 1, a balloon 30 has proximal portion 32, a
distal portion 34, and an intermediate portion 36 between the
proximal and distal portions 32, 34. The balloon 30 can comprise
any suitable configuration, for example as shown and described in
US Publication No. 2007/0106216 to Noddin, which is herein
incorporated by reference. In some embodiments, the balloon 30 has
a drug 26 disposed on at least portion of a balloon outer surface
38.
[0027] In some embodiments, the balloon 30 comprises a drug coated
balloon. As used herein, the term "drug coated balloon" is meant to
include a balloon with a drug coating on the balloon, a balloon
impregnated with a drug, a balloon having an excipient including a
drug, a balloon having a polymer including a drug, or any other
suitable balloon having a drug therein or thereon. Thus, in some
embodiments, the drug 26 is applied directly to the balloon outer
surface 38 or portion thereof. In some embodiments, the drug 26 is
formulated with an excipient. An excipient is an additive to a
drug-containing layer that facilitates adhesion to the balloon
and/or release from the balloon upon expansion. The excipient may
be a polymer, a contrast agent, a surface active agent, citrate
ester, or other small molecule, examples of which are disclosed in
U.S. Provisional Application No. 61/271,167 (Attorney Docket No.
563.2C-14586-US01) to Kangas et al. ("Nucleation of Drug Delivery
Balloons to Provide Improved Crystal Size and Density") and U.S.
Pat. No. 6,409,816, which are herein incorporated by reference. In
some embodiments, the drug 26 comprises a therapeutic agent. In
some embodiments, the drug 26 can be applied to the balloon 30 as
shown and described in US Publication No. 2007/0106216.
[0028] A therapeutic agent may be a drug or other pharmaceutical
product such as non-genetic agents, genetic agents, cellular
material, etc. Some examples of suitable non-genetic therapeutic
agents include but are not limited to: anti-thrombogenic agents
such as heparin, heparin derivatives, vascular cell growth
promoters, growth factor inhibitors, Paclitaxel, etc. Where an
agent includes a genetic therapeutic agent, such a genetic agent
may include but is not limited to: DNA, RNA and their respective
derivatives and/or components; hedgehog proteins, etc. Where a
therapeutic agent includes cellular material, the cellular material
may include but is not limited to: cells of human origin and/or
non-human origin as well as their respective components and/or
derivatives thereof. Where the therapeutic agent includes a polymer
agent, the polymer agent may be a
polystyrene-polyisobutylene-polystyrene triblock copolymer (SIBS),
polyethylene oxide, poly vinyl propylene (PVP), silicone rubber
and/or any other suitable substrate.
[0029] Turning to FIG. 2A, the balloon 30 and particulate filter 22
are shown in a delivery configuration 2. In the delivery
configuration 2, the balloon 30 and particulate filter 22 have a
reduced profile wherein the balloon 30 and the particulate filter
22 have a reduced cross-section to allow for intraluminal delivery
of the device.
[0030] As shown in FIG. 2B, the balloon 30 and particulate filter
22 are shown in an expanded configuration 4. As shown in FIG. 2B,
the balloon 30 and the particulate filter 22 are expanded to their
maximum respective intraluminal profiles. The term "maximum
intraluminal profile" refers to the largest possible cross-section
which the component (e.g., balloon, filter) attains during
deployment inside the body lumen. Thus, the "maximum intraluminal
profile" may in fact be smaller than any actual maximum profile,
for example if the device (or relevant component, e.g., balloon,
filter) were expanded outside of the body lumen. To that end, the
"maximum intraluminal profile" is the maximum profile attained
during deployment of the device within a body lumen.
[0031] FIG. 2C shows the balloon 30 and particulate filter 22 in
post-expansion configuration 6. In the post-expansion configuration
6, the profile of the balloon 30 is reduced from the expanded
configuration 4 of FIG. 2B. The filter 22 has as large, or nearly
as large, of a profile as in the expanded configuration 4. In this
way, the filter 22 (or a portion thereof) remains in contact with
the body lumen 40 even though the balloon 30 is reduced from its
expanded configuration 4.
[0032] With further reference to FIG. 2C, in some embodiments, the
filter 22 comprises a filter proximal portion 42 and a filter
distal portion 44. In some embodiments, the filter 22 has a
frusto-conical shape, for example as shown in FIG. 2C. In some
embodiments, frusto-conical shaped filter 22 has a base 46 (FIG.
3), and a length 48 (FIG. 3). In some embodiments, the filter has a
width 62. In some embodiments, the width 62 can also be referred to
as the diameter of the filter, for example where the filter has a
circular cross-section. In some embodiments, the base 46 is greater
than the length 48 when the filter is in an expanded configuration
4 or post-expansion configuration 6. In some embodiments, the
length 48 is greater than the width 62 of the base 46 when the
filter is in an expanded configuration 4 or post-expansion
configuration 6. The filter 22 can also comprise any suitable
shape, for example, conical, conical with an elliptical
cross-section, semi-spherical, cylindrical, or combinations
thereof. In addition, where the filter 22 is conical or
frusto-conical, it can be a right-cone, an oblique cone, or any
other suitably shaped cone. In some embodiments, the base 46 is
perpendicular to the longitudinal axis 54 of the balloon catheter
20 and/or body lumen 40. In some embodiments, the base 46 is
arranged at an oblique angle relative to the longitudinal axis of
the balloon catheter 20 and/or body lumen 40.
[0033] In some embodiments, the base 46 has a perimeter 52, for
example as shown in FIG. 3. In the post-expansion configuration 6,
the perimeter 52 can remain in contact with the body lumen 40 in
order to prevent drug particulates 16 from bypassing the filter
22.
[0034] Turning again to FIG. 2D, the balloon 30 and particulate
filter 22 are shown in an unexpanded configuration 8. When the
balloon 30 and particulate filter 22 are in the unexpanded
configuration 8, the balloon catheter 20 is able to be removed from
the body lumen. In the unexpanded configuration 8, both the filter
22 and the balloon 30 have a smaller profile than when the drug
loss protection device 10 is in its post-expansion configuration 6.
Although, in some embodiments, neither the filter 22 nor the
balloon 30 have as small a cross-sectional profile as when they are
in the delivery configuration 2, their respective profiles
nonetheless allow for extraction from the body lumen. Moreover, in
some embodiments, the filter 22 will have drug particulates trapped
in the filter 22 during removal of the balloon catheter 20.
[0035] With reference to FIG. 3, in some embodiments, the openings
28 of the filter 22 are larger in size near the filter proximal
portion 42 than near the filter distal portion 44. In some
embodiments, the openings 28 of the filter 22 are larger in size
near the filter distal portion 44 than near the filter distal
portion 42. In some embodiments, the openings 28 are all the same
size. In some embodiments, the openings change in size in relation
to the balloon inflation, deployment, and/or vessel size.
[0036] In some embodiments, the filter 22 of the drug loss
protection device 10 is configured to expand in conjunction with
the balloon 30. In some embodiments, at least a portion of the
filter 22 is engaged to a distal cone 35.
[0037] In some embodiments, the drug loss protection device 10
comprises a plurality of interconnecting members 60. As shown in
FIG. 3, the interconnecting members 60 extend from a portion of the
filter 22, for example the perimeter 52. The interconnecting
members 60 are further connected to a portion of the balloon 30,
for example, the distal cone 35. In some embodiments, as the
balloon 30 is expanded from a delivery configuration 2 (shown in
FIG. 2A) to an expanded configuration 4 (FIG. 2B), the perimeter 52
is also expanded, along with the filter 22. The interconnecting
members 60 can comprise any suitable metal, polymer, or other
material. In some embodiments, the interconnecting members 60
comprise a shape memory material. In some embodiments, the
interconnecting members 60 are self-expanding. In some embodiments,
the interconnecting members 60 are balloon expandable. In some
embodiments, the interconnecting members 60 comprise tethers.
[0038] Turning to FIG. 3B, in some embodiments, the drug loss
protection device 10 comprises a single interconnecting member 60.
In some embodiments, the interconnecting member is attached to a
guidewire 50, filter wire, or other suitable device. In some
embodiments, the filter 22 is attached as shown and described in
U.S. Pat. No. 7,476,236, which is herein incorporated by reference.
In some embodiments, the drug loss protection device 10 comprises a
plurality of interconnecting members 60 attached to the balloon,
guidewire 50, filter wire, or other suitable device. In some
embodiments, the filter 22 is attached to both the balloon 30 and
the guidewire or filter wire. In some embodiments, the filter 22 is
permitted to rotate with respect to the balloon 30, guidewire 50,
and/or filter wire.
[0039] In some embodiments, the interconnecting members 60 are
attached to the balloon, filter, guidewire 50, and/or filter wire
via an adhesive material. In some embodiments, the interconnecting
members 60 are attached by laser weld. In some embodiments, the
filter 22 is attached with a string or tether. In some embodiments,
one or more of the interconnecting members 60 is temporarily
attached. One or more of the interconnecting members can also be
permanently attached. In some embodiments, the filter 22 is
permitted to expand due to blood or fluid flow therethrough.
[0040] In some embodiments, the filter 22 can be expanded from a
delivery configuration 2 to an expanded configuration 4 by reducing
the length 48 of the filter 22. For example, where the filter 22 is
frusto-conical in shape, the width 62 of the base 46 is increased
as the length 48 of the filter 22 is decreased. In this way, the
configuration of the filter 22 can be selected independently of the
balloon configuration. Moreover, the filter 22 can remain in an
expanded configuration even as the balloon 30 is deflated from an
expanded configuration to a post-expansion configuration. In
addition, the filer 22 can remain in a post-expansion configuration
even where the balloon 30 is in an unexpanded configuration. Other
intermediate configurations for both the filter 22 and balloon 30
are also possible, at least where the filter and balloon are
capable of being independently configured.
[0041] In some embodiments, the length 48 of the filter 22 is
adjusted by expansion of the filter 22. In some embodiments, the
length 48 of the filter 22 is adjusted by a tether to the balloon
30, or guidewire, or the balloon 30 and the guidewire. In some
embodiments, the entire filter 22 is permitted to translate
distally or proximally relative to the balloon 30, guidewire 50,
and/or filter wire, allowing the filter 22 to be placed in the
desired location in the vessel or other body lumen. In some
embodiments, the filter distal portion 44 is permitted to translate
distally or proximally relative to the balloon 30, guidewire 50,
and/or filter wire. In some embodiments, the filter 22, or a
portion thereof can translate relative to the balloon 30 as the
balloon 30 is inflated or deflated. In some embodiments, the
balloon 30 inflation diameter controls the width 62 of the filter
22.
[0042] In some embodiments, for example as shown in FIG. 4, the
filter 22 has one or more folds 64. In some embodiments, the folds
64 of the filter 22 will be present in the delivery configuration
2. The filter 22 can also comprise folds 64 in an unexpanded
configuration 8 or in any other configuration.
[0043] In some embodiments, the filter 22 comprises an elastomeric
material and is thus permitted to expand without folds. Suitable
elastomeric materials include, nut are not limited to polyurethane,
silicone, and rubber. In some embodiments, the elastomeric material
is polyurethane having a durometer of between about 50 and 72.
Other suitable elastomeric materials can also be used. In some
embodiments, the filter 22 comprises both folds and an elastomeric
material. In some embodiments, the filter 22 comprises non-elastic
material. The filter 22 can also comprise shape memory metal or
polymer. Examples of suitable filter materials include, but are not
limited to Nitinol-block polymers, electro-active polymers (e.g.,
poly polypyrroles), and electro active metals (e.g., NiTi).
[0044] In some embodiments, for example as shown in FIG. 4, the
balloon 30 has one or more folds 66. In some embodiments, the folds
66 will be present when the balloon catheter 20 is in the delivery
configuration 2. The balloon 30 can also comprise folds 66 in an
unexpanded configuration 8 or in any other configuration.
[0045] In some embodiments, the balloon 30 comprises an elastomeric
material and/or one or more folds in conjunction therewith. The
balloon can also comprise materials such as, but not limited to,
those disclosed in U.S. Pat. No. 7,005,097, which is herein
incorporated by reference.
[0046] In some embodiments, at least a portion of the filter 22
extends longitudinally over at least a portion of the balloon 30,
for example as shown in FIG. 4. In some embodiments, at least a
portion of the filter proximal portion 42 extends over at least a
portion of the balloon distal portion 34. In some embodiments, the
filter base 46 encircles at least a portion of the balloon 30, for
example the balloon distal cone 35. In some embodiments, at least a
portion of the filter 22 extends longitudinally over at least a
portion of the balloon 30 in a delivery configuration 2. In some
embodiments, at least a portion of the filter 22 extends
longitudinally over at least a portion of the balloon 30 when
either of the filter 22, the balloon 30, or both are in a delivery
configuration. In some embodiments, at least a portion of the
filter 22 extends longitudinally over at least a portion of the
balloon 30 when either of the filter 22, the balloon 30, or both
are in an expanded configuration. In some embodiments, at least a
portion of the filter 22 extends longitudinally over at least a
portion of the balloon 30 when either of the filter 22, the balloon
30, or both are in a post-expansion configuration. In some
embodiments, at least a portion of the filter 22 extends
longitudinally over at least a portion of the balloon 30 when
either of the filter 22, the balloon 30, or both are in an
unexpanded configuration. In some embodiments, the filter 22 is
longitudinally offset from the balloon. In some embodiments, the
filter does not overlap the filter.
[0047] Turning now to FIG. 5, in at least one embodiment, the drug
loss protection device 10 further comprises a stent 70 encircling
at least a portion of the balloon 30. Suitable stents include, but
are not limited to, those disclosed in U.S. Pat. No. 6,896,696 and
US Publication Nos. 2002/0095208 and 2009/0240324, which are herein
incorporated by reference.
[0048] In some embodiments, the stent 70 comprises a drug coated
stent, a drug impregnated stent, a drug eluting stent, or any other
suitable stent.
[0049] When used in conjunction with a drug eluting stent, the
filter 22 of the drug loss protection device 10 can filter
particulates that are emitted from the stent and/or balloon 30
during deployment of the stent 70 and/or expansion of the balloon
30.
[0050] In some embodiments, the stents are made from any suitable
biocompatible materials including one or more polymers, one or more
metals or combinations of polymer(s) and metal(s). Examples of
suitable materials include biodegradable materials that are also
biocompatible. By biodegradable is meant that a material will
undergo breakdown or decomposition into harmless compounds as part
of a normal biological process. Suitable biodegradable materials
include polylactic acid, polyglycolic acid (PGA),
poly(lactic-co-glycolic) acid (PLGA), collagen or other connective
proteins or natural materials, polycaprolactone, hylauric acid,
adhesive proteins, co-polymers of these materials as well as
composites and combinations thereof and combinations of other
biodegradable polymers. Other polymers that may be used include
polyester and polycarbonate copolymers. Examples of suitable metals
include, but are not limited to, stainless steel, titanium,
tantalum, platinum, tungsten, gold and alloys of any of the
above-mentioned metals. Examples of suitable alloys include
platinum-iridium alloys, cobalt-chromium alloys including Elgiloy
and Phynox, MP35N alloy and nickel-titanium alloys, for example,
Nitinol.
[0051] In some embodiments, the stents are made of shape memory
materials such as superelastic Nitinol or spring steel, or are made
of materials which are plastically deformable. In the case of shape
memory materials, in some embodiments, the stent is provided with a
memorized or pre-set shape and then deformed to a reduced diameter
shape. The stent may restore itself to its memorized or pre-set
shape upon being heated to a transition temperature and having any
restraints removed therefrom.
[0052] In some embodiments, the stents are created by methods
including cutting or etching a design from a tubular stock, from a
flat sheet which is cut or etched and which is subsequently rolled
or from one or more interwoven wires or braids. Any other suitable
technique which is known in the art or which is subsequently
developed may also be used to manufacture the stents disclosed
herein.
[0053] In some embodiments, the drug loss protection device 10
further comprises a stent-graft, graft, or any other suitable
luminal scaffolding device.
[0054] In some embodiments, at least a portion of the drug loss
prevention device is configured to include one or more mechanisms
for the delivery of a therapeutic agent. In some embodiments, the
stent will include one or more such mechanisms. Often the agent
will be in the form of a coating or other layer (or layers) of
material placed on a surface region of the stent or balloon, which
is adapted to be released at the site of the stent's implantation
or areas adjacent thereto.
[0055] In at least one embodiment, for example as shown in FIG. 6,
a drug loss protection device 110 comprises a balloon 30 and a
filter 122. The filter 122 is adjacent to the balloon 30 and
encircles at least a portion of the balloon 30. The balloon 30 can
have a drug 26 disposed thereon or within a portion of the wall of
the balloon. The filter 122 thereby surrounds the drug 26.
[0056] In some embodiments, the filter 122 comprises a mesh 124
which defines a plurality of openings 128. The size of the openings
128 is determined according to the size of drug particulates which
are to pass through the openings 128, or conversely, according the
size of drug particulates which are not to pass through the
openings 128. Upon expansion of the balloon 30, the drug is pushed
radially outwardly through the openings 128 and onto the adjacent
luminal surface 41. Drug particulates larger than the openings 128
are not permitted to leave the filter 122, and thus do not exit the
confines of the drug loss protection device 110. As such,
particulates larger than the predetermined size are not permitted
to freely enter a blood stream, for example where the drug loss
protection device 110 is used in an artery or vein. In some
embodiments, the openings change in size in relation to the balloon
inflation, deployment, and/or vessel size.
[0057] After delivery of the drug 26, the balloon 30 of the drug
loss prevention device 110 is deflated and the filter 122 and the
balloon 30 assume a reduced profile. Drug particulates that were
too large to pass through the openings 128 of the filter 122 are
retained by the filter 122 and removed from the body lumen 40 along
with the balloon catheter.
[0058] In some embodiments, the openings 28, 128 comprise pores,
for example where the filter material is a porous polymeric
material, expanded polytetrafluoroethylene, (ePTFE), or a
hydrogel.
[0059] In some embodiments, any of the filters disclosed herein can
also be used as an embolic filter.
[0060] Turning to FIG. 7, in some embodiments, the drug loss
protection device 210 comprises both a filter 22 and a filter 122.
In some embodiments, the filter 122 has openings 128 that are
larger than the openings 28 of the filter 22, for example where two
stages of filters are desired. In some embodiments, the filter 122
has openings 128 that are smaller than the openings 28 of the
filter 22, for example where filter 128 is configured to filter a
first size of drug particulates 16 and filter 22 is configured to
filter a second size of drug particulates. In some embodiments, the
first size of drug particulates is larger than the second size of
drug particulates. In some embodiments, the filter 122 is
configured to filter out drug particulates and filter 22 is
configured as an embolic filter. In this way, the drug protection
device 210 has one filter which filters drug particulates and
another filter which filters embolic material. Other suitable
combinations and configurations of drug and embolic particulate
filters are also contemplated. In some embodiments, the total
number of filters can be more than one or two. In some embodiments,
the number of filters can vary.
[0061] In some embodiments, the stent, the delivery system, the
drug loss protection device, or other portion of the assembly
includes one or more areas, bands, coatings, members, etc. that is
(are) detectable by imaging modalities such as X-Ray, MRI,
ultrasound, etc. In some embodiments at least a portion of the
stent and/or adjacent assembly is at least partially
radiopaque.
[0062] Description of some exemplary embodiments is contained in
the following numbered paragraphs:
1. An intravascular drug loss protection device comprising:
[0063] a drug-coated balloon comprising a drug coating; and
[0064] a drug particulate filter distal to the drug-coated balloon,
the drug particulate filter comprising a mesh, the mesh defining a
plurality of openings configured to selectively prevent the passage
of drug particulates therethrough.
2. The drug loss protection device of paragraph 1, wherein the
drug-coated balloon and drug particulate filter each comprise a
delivery configuration, an expanded configuration, a post-expansion
configuration, and an unexpanded configuration;
[0065] the drug-coated balloon having a profile in each of the
delivery configuration, expanded configuration, post-expansion
configuration, and unexpanded configuration;
[0066] the particulate filter having a profile in each of the
delivery configuration, expanded configuration, post-expansion
configuration, and unexpanded configuration;
[0067] the profile of the drug-coated balloon in the expanded
configuration being larger than in each of the delivery
configuration, post-expansion configuration, and the unexpanded
configuration;
[0068] the profile of the particulate in the expanded configuration
being the same as in the post-expansion configuration.
3. The drug loss protection device of paragraph 1, wherein the drug
particulate filter has a proximal end and a distal end, the drug
particulate filter tapering from the proximal end to the distal
end. 4. The drug loss protection device of paragraph 1, wherein the
plurality of openings comprises openings of various sizes. 5. The
drug loss protection device of paragraph 1, wherein the plurality
of openings comprises openings that are all the same size. 6. The
drug loss protection device of paragraph 1, wherein the openings
are between 10 and 500 microns in size. 7. The drug loss protection
device of paragraph 1 further comprising a stent encircling at
least a portion of the drug-coated balloon. 8. The drug loss
protection device of paragraph 7, wherein the stent comprises a
drug eluting stent. 9. The drug loss protection device of paragraph
1 wherein the filter has a shape consisting of: semi-spherical,
conical, frusto-conical, cylindrical, semi-cylindrical, and
combinations thereof 10. An intravascular drug loss protection
device comprising:
[0069] a drug-coated balloon comprising a drug coating;
[0070] a stent encircling at least a portion of the drug-coated
balloon and engaged thereto; and
[0071] a drug particulate filter longitudinally adjacent to the
drug-coated balloon and stent, the drug particulate filter defining
a plurality of openings configured to selectively capture drug
particulates.
11. The drug loss protection device of paragraph 10, wherein the
filter is attached to a portion of the drug-coated balloon. 12. The
drug loss protection device of paragraph 10, wherein the filter has
a proximal portion, a distal portion, and a tapered profile
tapering from the proximal portion to the distal portion. 13. The
drug loss protection device of paragraph 12, wherein the filter is
frusto-conical. 14. An intravascular drug loss protection device
comprising:
[0072] a drug coated balloon comprising a drug coating; and
[0073] a drug particulate filter encircling at least a portion of
the drug coated balloon; the drug particulate filter comprising a
mesh, the mesh defining a plurality of openings sized to
selectively prevent the passage of drug particulates
therethrough.
15. The drug loss protection device of paragraph 14, wherein the
openings are between 10 and 500 microns in size 16. A method for
preventing drug loss into a body lumen comprising the steps of:
[0074] providing a drug-coated balloon comprising a drug
coating;
[0075] providing a drug particulate filter adjacent to the
drug-coated balloon;
[0076] expanding the drug particulate filter;
[0077] expanding the drug-coated balloon;
[0078] releasing drug particulates;
[0079] selectively capturing drug particulates in the drug
particulate filter;
[0080] at least partially collapsing the drug particulate filter
and balloon;
[0081] removing the drug-coated balloon and drug particulate filter
from the body lumen.
17. The method of paragraph 16, wherein the step of releasing drug
particulates comprises releasing drug particulates from the
drug-coated balloon. 18. The method of paragraph 16 further
comprising the step of providing a stent disposed around at least a
portion of the drug-coated balloon. 19. The method of paragraph 16,
wherein the drug coating comprises a plurality of drugs.
[0082] The above disclosure is intended to be illustrative and not
exhaustive. This description will suggest many variations and
alternatives to one of ordinary skill in this art. The various
elements shown in the individual figures and described above may be
combined or modified for combination as desired. All these
alternatives and variations are intended to be included within the
scope of the claims where the term "comprising" means "including,
but not limited to".
[0083] Further, the particular features presented in the dependent
claims can be combined with each other in other manners within the
scope of the Application such that the scope should be recognized
as also specifically directed to other embodiments having any other
possible combination of the features of the dependent claims. For
instance, for purposes of claim publication, any dependent claim
which follows should be taken as alternatively written in a
multiple dependent form from all prior claims which possess all
antecedents referenced in such dependent claim if such multiple
dependent format is an accepted format within the jurisdiction
(e.g. each claim depending directly from claim 1 should be
alternatively taken as depending from all previous claims). In
jurisdictions where multiple dependent claim formats are
restricted, the following dependent claims should each be also
taken as alternatively written in each singly dependent claim
format which creates a dependency from a prior
antecedent-possessing claim other than the specific claim listed in
such dependent claim below.
[0084] This completes the description. Those skilled in the art may
recognize other equivalents to the specific embodiment described
herein which equivalents are intended to be encompassed by the
claims attached hereto.
* * * * *